BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1890757 · Received November 1, 2010

    Report

    Report Number
    1717344-2010-00764
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 7, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PANCREATECTOMY, THE KNIVES CAME OFF THE TRACK AND JAMMED IN THE INSTRUMENTS. THERE WAS NO TISSUE LOSS OR BLEEDING GREATER THAN 250CC REPORTED. THE PT IS CURRENTLY IN GOOD CONDITION. THIS OCCURRED WITH FOUR DEVICES DURING THE PROCEDURE. THE OTHER DEVICES CAN BE REFERENCE ON MFR. REPORT #'S: 1717344-2010-00765, 1717344-2010-00763, 1717344-2010-00762.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) LF4200 188765

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR